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        "reason": "Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change."
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        "reason": "Complaints have been received regarding post-operative implant collapse."
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    {
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    {
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    {
      "code": "MQP",
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    {
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}
